MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS, INC. COMBO INSERTER/IMPACTOR. XS

Model Number	IMP-0926-030-00A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during a tsa surgery, while inserting the fin-lock implant into the patient, the combo inserter/impactor.Xs broke off.The broken pieces were removed with forceps and suction from the patient.The procedure was performed, without any delay, using the same device.No injury was reported as a consequence of this issue.
Additional Manufacturer Narrative
H3, h6: the product has not been returned to the aus site for evaluation and photographs were not provided, so the reported event could not be confirmed.The following investigative actions were performed.Complaint history review: the complaint history review identified similar reported events for this device.No adverse trend was identified.Future complaints for this failure mode will continue to be monitored and investigated as required.Risk management review (device): identified no issues which could have caused or contributed to the reported event.The failure mode was previously identified by the risk management file and the anticipated risk level is acceptable.Capa/nc/pra/hhe/field action review: identified no previous events or issues which could have caused or contributed to the reported event.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.Device labeling/ifu review: identified no issues which could have caused or contributed to the reported event.This review determined that the device met labeling requirements upon release for distribution.Product prints/specifications/procedure review: identified no issues which could have caused or contributed to the reported event.This review determined that the device met product specifications upon release for distribution.Dhr/batch record review: as the product lot number was not reported, the dhr/batch record review could not be completed.Visual inspection: visual inspection was unable to be performed because the device has not been received for evaluation.The complaint alleges no injury to the patient nor a delay during surgery.As the device has not been returned for evaluation, it could not be determined whether the device contributed to the reported event.As the product lot number was not reported, it could not be determined whether the device met manufacturing specifications.As the device has not been returned for evaluation, a definitive root cause could not be determined.The fin-lock combo inserter/impactor is a reusable instrument expected to be used across multiple surgeries.During normal use, the inserter grips the fin-lock glenoid implant and secures it to the glenoid impactor handle.It places the glenoid implant in the correct location and then protects the implant while the handle is being impacted with a mallet to seat the implant.Therefore, the inserter may fail if excessive force is applied during impaction or may weaken over time due to normal wear.Additionally, due to the geometry of the instrument, the inserter may be broken if mishandled, such as by resting a heavy object on top of the device while the bottom is unsupported.Based on this investigation, the need for corrective action is not indicated as no non-conformances nor manufacturing deficiencies were identified and the risk level is acceptable.If additional information is later received, the complaint may be reopened.No further investigation is warranted for this complaint, though future complaints will be monitored and investigated as required.This investigation can be closed.
Event or Problem Description
It was reported that during a tsa surgery, while inserting the fin-lock implant into the patient, two combo inserter/impactor.Xs broke off.The broken pieces were removed with forceps and suction from the patient.The procedure was performed, without any delay, using the same device.No injury was reported as a consequence of this issue.
Additional Manufacturer Narrative
The associated devices were returned and evaluated.The visual inspection revealed that a piece of the reusable instruments were fractured off.Additional signs of wear were identified along the edges of the devices, specifically indents and scratches.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history revealed similar events for the listed devices over the previous 12 months, but no similar events for the batches based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to these products and event.At this time, we have no evidence to conclude that the products failed to meet any specifications at the time of manufacture.These devices are reusable instruments that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely potential factors that could contribute to the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: COMBO INSERTER/IMPACTOR. XS
• Common Device Name: IMPACTOR
• Manufacturer (Section D): ASCENSION ORTHOPEDICS, INC.; 11101 metric blvd; austin TX 78758
• Manufacturer (Section G): ASCENSION ORTHOPEDICS, INC.; 11101 metric blvd; austin TX 78758
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 16924684
• Report Number: 3002788818-2023-00037
• Device Sequence Number: 6921799
• Product Code: HWA
• UDI-Device Identifier: 00885556860724
• UDI-Public: 00885556860724
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: IMP-0926-030-00A
• Device Catalogue Number: IMP-0926-030-00A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2023
• Supplement Date Received by Manufacturer: 06/09/2023; 02/13/2024
• Initial Report FDA Received Date: 05/12/2023
• Supplement Report FDA Received Date: 06/13/2023; 02/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown